Difamilast
As of the edition of 20 October 2026, Difamilast is a small molecule: marketed, first approved in 2021 (JP); acts on PDE4A, PDE4B and PDE4C and 1 more; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Adquey
- First approved
- 27 September 2021 (JP)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Acrotech Biopharma; 2 holders in all
- Registered trials
- 15, 0 stopped early
- Disease areas
- Immune system; Inherited and neonatal; Skin and connective tissue
US protection
US protection ends in 2036.
The last listed US drug-substance patent ends in 2036. The application that gives this date is held by Acrotech Biopharma.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Difamilast.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 9 | 7 | 2 | 0 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Applicant and Lead sponsor of trials | 2012 to now |
| Acrotech Biopharma | Applicant and Lead sponsor of trials | 2022 to now |